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Serving leading biopharmaceutical companies globally:

Express Scripts
Covington
QuintilesIMS
Moodys
Citi
Fish and Richardson
Boehringer Ingelheim
US Army
Colorcon
AstraZeneca

Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207322

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NDA 207322 describes POLYMYXIN B SULFATE, which is a drug marketed by X Gen Pharms, West-ward Pharms Int, Gland Pharma Ltd, Paddock Llc, Xellia Pharms Aps, Fresenius Kabi Usa, and Aurobindo Pharma Ltd, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the POLYMYXIN B SULFATE profile page.

The generic ingredient in POLYMYXIN B SULFATE is polymyxin b sulfate. There are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate profile page.

Summary for 207322

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 207322

Ingredient-typePolymyxins

Medical Subject Heading (MeSH) Categories for 207322

Suppliers and Packaging for NDA: 207322

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POLYMYXIN B SULFATE
polymyxin b sulfate
INJECTABLE;INJECTION 207322 ANDA Alvogen Inc. 47781-596 47781-596-91 10 VIAL in 1 CARTON (47781-596-91) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (47781-596-07)
POLYMYXIN B SULFATE
polymyxin b sulfate
INJECTABLE;INJECTION 207322 ANDA Breckenridge Pharmaceutical, Inc. 51991-939 51991-939-17 10 VIAL, SINGLE-USE in 1 CARTON (51991-939-17) > 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-USE (51991-939-99)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500,000 UNITS BASE/VIAL
Approval Date:Apr 14, 2016TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

US Department of Justice
Julphar
Deloitte
Argus Health
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McKinsey
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Queensland Health
Cerilliant
Cantor Fitzgerald

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